21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation
The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam formulation.
Drug: azelaic acid pre-foam formulation
Drug: Vehicle pre-foam formulation
Drug: Sodium lauryl sulfate
|Study Design:||Intervention Model: Single Group Assignment|
|Official Title:||A Randomized, Double-blind, Vehicle-controlled Phase 1 Dermal Safety Study Using a 21 Day Cumulative Irritant Patch Test Design to Evaluate the Local Tolerability of Azelaic Acid Pre-Foam Formulation in Healthy Volunteers|
- irritancy rating scale [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]skin reaction as well as superficial layer effects will be scored according to standardized scales
|Study Start Date:||September 2011|
|Experimental: Verum||Drug: azelaic acid pre-foam formulation|
|Placebo Comparator: Vehicle||Drug: Vehicle pre-foam formulation|
|Placebo Comparator: Negative control||Drug: Water|
|Active Comparator: Positive control||Drug: Sodium lauryl sulfate|
This is the standard patch test over 21 days of exposure of the test product,its vehicle and a positive as well as a negative control.